BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1882064 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04426
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDICAL SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A COLONOSCOPY PROCEDURE (EVENT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS SET ON BLEND MODE AT 23 TO 25, AND THE ENERGY OUTPUT WAS DRIFTING DOWN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. FOLLOWING THE PROCEDURE, THE CONSOLE PASSED THE PREVENTIVE MAINTENANCE INSPECTION. BIPOLAR MODE WAS ALSO INSPECTED AND WORKS CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS MEDICAL SCIENTIFIC M0054080R0

    Patients

    Seq Age Sex Outcome Treatment
    1